- Merck (St. Paul, MN)
- **Job Description** The Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality ... SMEs. **Job Function:** + serve as a subject matter expert for good manufacturing practices ( GMP ) for...authority/board of health as an inspector, investigator, product reviewer, compliance officer, or other GMP /regulatory role +… more
- Fujifilm (St. Paul, MN)
- …regard to biologically contaminated solid waste materials, serve as the subject matter expert for laboratory safety, be a resource to EHS teams for facility safety ... audits, and represent FDB as a biosafety subject matter expert . This role will have 7-10 direct and indirect...certifications, and related work experience. + Strong understanding of GMP principals and working within a quality centric organization… more
- Fujifilm (St. Paul, MN)
- …management systems for FUJIFILM Diosynth Biotechnologies (FDB) to ensure excellence in compliance and the ability to withstand internal and external scrutiny. The ... ensure that internal audit controls are implemented and are evaluated for compliance through audits and assessments across the FDB functions to minimize regulatory,… more
- Kelly Services (Minneapolis, MN)
- …to maximize efficiency and effectiveness while staying within budget and regulatory compliance with FDA, ISO, and GMP standards. + **Laboratory Operations:** ... our QC team in driving quality excellence, process optimization, and regulatory compliance across our laboratory operations. This role is pivotal in ensuring our… more
- United Therapeutics (Eden Prairie, MN)
- …or increase compliance /safety/ease of use + Ensure that the team meets all compliance , OSHA, and GMP requirements and that work is documented + Review and ... cause is correctly identified + Serve as a technical expert , train and onboard employees in documentation and process...SOPs, and MBRs, and submit SOPs and MBRs in compliance with Quality standards + Be responsible for scheduling,… more
- Abbott (St. Paul, MN)
- …their intended functions in a safe and effective manner and establishes compliance with the quality system. They organize and drive cross-functional collaboration ... + Support DHF content completion, integrity, and regulatory & standards compliance ; collaboratively communicating & resolving gaps + Maintain Risk Management… more